Medical Device Documentation Best Translation Practices

How Medical Device Translation Services Approach the Approval Process

Medical Device Documentation Best Translation PracticesYou should always expect excellence when it comes to localizing and translating your company’s medical device documentation. Don’t approach translated device documents, which include labels, instructions for use (IFU) and packaging, as an afterthought, especially when trying to enter a foreign market.

The global medical device market, the labeling requirements that vary from country to country, and the medical device document translation services supporting manufactures all come together to create a dynamic system with many different moving parts. These different parts are often hard to keep track of due to regional and national regulatory rules, which are often in flux.

Here are four core best practices to follow during the translation process that, as a general rule, can help guarantee quality medical device documentation translations, regardless of the local regulations and languages your translation service has to contend with.

1. Clear and Concise Medical Device Instructions

Seasoned medical device document translation services need to prepare manufacturers accustomed to the American Food and Drug Administration’s (FDA) application process for extra regulatory hurdles when it comes to obtaining device approvals overseas. Creating clear, concise and consistent medical device instructions is one of the most vital components in streamlining this process, and keeping costs as low as possible.

Looking at the European Union (EU) as a prime example, with its big list of language requirements, we quickly see how adhering to simple, clear and concise translations can help companies avoid complications. In order to get the coveted CE marking and logo, which signifies that “products sold in the EEA [European Economic Area] have been assessed to meet high safety, health, and environmental protection requirements,” device manufactures usually need to provide translations of their device’s instructions for use into the EU’s 24 official languages. And these translations need to be extremely precise, and consistently translated (i.e. the content is the same) in all 24 languages.

Useful Medical Writing Techniques

When dealing with anything medical, translate clearly and concisely. Always. This means steering clear of acronyms, which vary from language to language, and abbreviations, which also vary widely. Avoid idioms and unnecessarily complicated terminology as they often don’t translate well across languages. When a simpler linguist choice is available that gets the point across, go with that — and of course avoid slang, no matter how trendy certain colloquial terms might be at the moment.

Adhering to simple, clear and concise terminology — while also compiling a project-specific glossary used as a reference, and as a resource for any technical jargon or abbreviations that just can’t be avoided — will help ensure that the translated documents, which include IFUs, product labels and more, will comply with the EU’s Medical Device Directive (and get its CE mark), or the directives governing the parts of the world a manufacturer is trying to crack open.

2. Rely on Human Translation with Medical Expertise

While machine translation has its place, when it comes time to translate healthcare documentation, medical device companies can’t afford mistakes. Translation snafus can potentially be devastating to a firm’s image, and its financial health. This is why, as a best practice, always work with an ISO certified medical translation company that relies on the skills provided by professional human translation services.

Specialized medical translators — in-country and with extensive medical experience, supported by professional project managers in a translation company’s main office — serve as a bulwark against errors coming from translators not trained in the medical field.

By working with qualified human translation services, and translation specialists with expertise related to your specific medical device, you can guarantee error-free, easy-to-understand translated text. It’s always a best practice to involve qualified human translators and project managers during the translation process, to build, check, and then triple check the final results.

3. Translate Healthcare Labeling Dynamically

Translate healthcare and medical device labeling dynamically. By “dynamically,” we mean using all of the tricks and tools available to your medical translation company.

For example, as we’ve already touched upon, shun industry lingo and jargon on your labels, and write (translate) clearly and concisely, making device labels a cinch to read and understand at first glance … in any language.

When allowed, also try to use well-known symbols that transcend languages and borders, as outlined by ISO 15223-1:2016, such as the international symbols for “caution,” “manufacturer,” “keep dry,” “fragile, handle with care,” and “biological risk.” By including symbols whenever possible, the device labeling becomes more attention-grabbing (what any good label should do), while simultaneously decreasing the danger of adding improperly translated text, as well as keeping the labeling succinct (symbols usually take up less room than text).

Concise, jargon-free translated text, symbols, and even easy-to-understand images and graphics can help you gain access to foreign markets by making your medical device labeling ridiculously simple to comprehend. It will also reduce translation and quality assurance costs.

4. Stay Up-to-Date with International Medical Device Documentation Requirements 

While it might seem painfully obvious to most, we can’t stress enough how important it is to stay up-to-date with medical device documentation translation requirements for the regions you’re working in. The medical device industry is massive, and national regulators are constantly altering and updating local regulations to deal with new technologies, emerging device sectors, and even device trends that might be hitting the local news.

By working with an ISO certified translation service, you can get the help you need to translate customer-facing content like device labels, packaging, IFUs, online instructions and promotional materials, as well as materials meant exclusively for medical professionals.

It’s a lot to keep track of, which is why you should select an experienced medical translation company that works with knowledgeable medical translators who can handle device regulations in different countries. These translation specialists are motivated to provide you with translated medical device content that’ll get your company into international markets as smoothly, efficiently and affordably as possible.


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